Regulatory Operations Specialist

Intuitive; Sunnyvale (CA); On-site; USD 89,000 - 105,000; Full time

Job summary

Intuitive Surgical is seeking a Regulatory Operations Specialist to provide regulatory and operational support for global product launches and site registrations. You will draft standardized technical documentation, assist with facility transfers, and collaborate with cross-functional teams to improve regulatory tools and processes.

The role requires 0–2 years in medical devices, strong attention to detail, and proficiency in MS Word/Excel/Outlook, with opportunities to grow in regulatory

Qualifications

• Minimum 0-2 years relevant experience in a medical device company.
• Essentials of Data Structure and Algorithms, Software Design and Architecture
• Strong attention to detail and ability to follow procedures, processes, and instructions
• Good communication (written and oral) and organizational skills
• Ability to perform multiple tasks in a fast-paced environment

Responsibilities

• Provide regulatory and operational support for new country product launches and global site registrations.
• Prepare Standardized Technical Documentation for medical devices for global submissions
• Assist with facility transfers and manufacturing line transfer projects
• Draft and update regulatory procedures and work tools to promote efficiency
• Review procedures and identify process improvements based on data and user experience
• Collaborate with development teams to design tools and applications for regulatory workflows
• Support audit team in preparing documents for audits

Skills

Regulatory operations

Technical documentation

Attention to detail

Communication skills

MS Office

Education

Bachelor's degree in science

Master's degree or foreign equivalent

Tools

MS Word

Excel

Outlook

Job description

• Ways of Working: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type: Employee
• Min. Salary Region 1: 104600 USD
• Global Job Level (HCM): Professional 2 (7)
• Min. Salary Region 2: 88900 USD

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position:

Provide regulatory and operational support for new country product launches, global new site registrations and site renewals for Intuitive and Third-party sites

Prepare Standardized Technical Documentation for medical devices to be used across submissions globally

Assist with Intuitive facility transfers and manufacturing line transfer projects

Communicate cross-functionally, including corporate departments and global departments, to improve regulatory tools and corporate processes that may impact or are related to regulatory

Draft and update regulatory department procedures and work process tools to promote efficiency and productivity. These may include templates, forms, SOPs, work instructions, checklists, trackers, etc.

Review procedures and identify process improvements based on data and user experience

Collaborate with development teams to help design tools and applications for Regulatory processes and workflows

Support audit team in preparing documents for use in audits

Collaborate with development teams to help design tools and applications for Regulatory processes and workflows

Draft and update regulatory department procedures and work process tools to promote efficiency and productivity. These may include templates, forms, SOPs, work instructions, checklists, trackers, etc.

Review procedures and identify process improvements based on data and user experience.

Assist with Intuitive facility transfers and manufacturing line transfer projects.

Qualifications

Required Skills and Experience:

Minimum 0-2 years relevant experience working in a medical device company; preferred 1-2 years of experience working in regulatory operations or software development

Essentials of Data Structure and Algorithms, Software Design and Architecture

Strong attention to detail and ability to follow procedures, processes, and instructions

Good communication (written and oral) and organizational skills

Ability to perform multiple tasks in a fast-paced environment

Motivated to excel and work in a team environment

Excellent customer service and interpersonal skills

Ability to deal with problems/issues in a professional manner

Understand implications of work and make recommendations for improvements in processes

Excellent skills in MS Word, Excel, and Outlook; capacity to learn additional software

Identifies and solves basic problems

Experience in writing Technical specifications, User Requirements, Functional Requirements preferred, but not required

Required Education and Training:

Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, biomedical engineering), math, engineering, or medical fields with 4-5 years’ experience OR

Master's degree or foreign equivalent in Biomedical Engineering, Regulatory Science, Life Science, Pharmacy, or a related field with 1 – 2 years’ experience.

Working Conditions:

None

Preferred Skills and Experience:

Strong attention to detail and ability to follow procedures, processes, and instructions

Understand implications of work and make recommendations for improvements in processes

Excellent skills in MS Word, Excel, and Outlook; capacity to learn additional software

Good communication (written and oral) and organizational skills

Ability to perform multiple tasks in a fast-paced environment

Motivated to excel and work in a team environment

Experience in writing Technical specifications, User Requirements, Functional Requirements preferred, but not required

Essentials of Data Structure and Algorithms, Software Design and Architecture

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer.We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

U.S. Export Controls Disclaimer:In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [e-mail].

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.